Comparison of Electrodessication, KTP Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata - Full Text View

Sponsored by:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00791908

Purpose

The primary objective of this study is to determine whether laser treatments over 6 weeks using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are effective in patients with cherry angiomas as observed by a physician provider and the subject.

The investigators hypothesize that the two laser treatments will be an effective tool for treating cherry angiomas. The investigators aim to compare these modalities to electrodessication, as all three modalities are considered the current standard of care. Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas.

In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of care, electrodessication.

Condition	Intervention
Cherry Angioma	Procedure: Electrodessication Procedure: PDL Procedure: KTP

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment
Official Title:	Comparison of Electrodessication, KTP Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Color, size, and texture changes of the cherry angioma [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient's satisfaction with treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	September 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
electrodessication: Active Comparator electrodessication	Procedure: Electrodessication Treatment applied to a third of the torso at each study visit.
PDL: Experimental pulsed dye laser	Procedure: PDL Laser treatment applied to a third of the torso at each study visit.
KTP: Experimental potassium titanyl phosphate (KTP) laser	Procedure: KTP Laser treatment applied to a third of the torso at each study visit.

Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 to 95 years.
Have at least 12 cherry angiomas (4 per each third of the torso) that have been documented.
The subjects are in medically stable condition.
The subject has willingness and the ability to understand and provide informed consent for the procedure and is able to communicate with the investigator.
Must be willing not to employ other treatment options for cherry angiomas during the course of this study.

Exclusion Criteria:

Under 18 years of age and over 95 years of age
Pregnancy or lactation.
Subjects who are unable to understand the protocol or to give informed consent.
Subjects cannot have had previous laser treatment in the last 6 months before enrollment.
Subjects have a cardiac defibrillator or pacemakers that may interact with the electrodesiccation technique.
Subjects have no serious medical conditions that would contradict participation in the research.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791908

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Murad Alam, MD

Northwestern University

More Information

Responsible Party:	Northwestern University ( Murad Alam )
Study ID Numbers:	MA-stu81
Study First Received:	November 14, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00791908
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hemangioma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on January 16, 2009